Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary
FDA device recall Z-1045-2017 · posted 2017-01-18 · Terminated
Recall details
- Recalling firm
- DICOM GRID INC
- Reason for recall
- A software error caused the window/level to become the same in one series regardless if the image had different levels; image results have a washed-out grey appearance.
- Action taken
- On 12/16/16 a fix is the software issue was conducted via remote cloud system. On 01/11/17 customers were sent Release Notes that addressed the software correction. The issue was resolved and required no further action.
- Root cause
- Software change control
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 209
- Distribution
- U.S. distribution to the following; TX, FL, NE, CA, WI, AZ, NH, MO, MA, CO, PA, NV, PR, IL, OH, NY, MD, NJ, MN, MI, CT, VA, GA, UT, KS, WA, MI, HI. Foreign distribution to the following; Canada, Spain
- Date initiated
- 2016-12-16
- Date posted
- 2017-01-18
- Date terminated
- 2017-04-07
- Location
- Phoenix, AZ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DG PACS (K152977) | Dicom Grid, Inc. | 2016-01-25 |